Project Manager

Job Title: Principal Engineer / Program Manager Job Description The Principal Engineer / Program Manager leads the execution of one or more concurrent medical device product development programs from concept through commercialization. This role combines technical leadership with full program ownership, ensuring that product development projects meet cost, schedule, quality, and performance objectives. The position manages a portfolio of development programs, coordinates cross‑functional teams, and serves as a primary point of contact for internal stakeholders and external partners throughout the product development life cycle. Responsibilities Own full‑cycle development project plans and deliverables for one or more simultaneous medical device products under development. Lead multi‑departmental, cross‑functional teams through the complete product development life cycle, from early concept and feasibility through verification, validation, and commercialization. Track project progress and milestones, analyze variances, and develop and implement recovery plans when deviations from cost, schedule, or performance targets occur. Maintain overall accountability for program costs, schedules, and performance, ensuring alignment with organizational goals and regulatory requirements. Serve as the primary liaison to key stakeholders, providing timely and transparent updates on project milestones, risks, issues, and overall progress. Report team progress and recommendations on a regular basis, including risk mitigation strategies and resource needs. Lead core team meetings, set clear objectives, define priorities, and document decisions, action items, and outcomes. Apply appropriate project management techniques and methodologies tailored to the specific needs, risks, and complexity of each program. Resolve cross‑functional barriers, facilitate effective collaboration, and delegate tasks appropriately across engineering, operations, quality, and other functions. Collaborate with functional leaders to address resource constraints, balance workloads, and ensure that project teams have the support needed to meet deliverables. Serve as a hands‑on technical resource throughout the project, contributing to engineering decisions and problem‑solving activities. Perform investigational and early verification testing to assess design feasibility, performance, and reliability. Evaluate and resolve project issues impacting manufacturability, reliability, and product performance, working closely with design, process, and manufacturing engineering. Engage with vendors and external partners for equipment, components, and services, ensuring that technical and quality requirements are clearly defined and met. Utilize rapid prototyping, machine shop tools, and molding and extrusion methods to support design iteration, prototyping, and process development. Ensure that department and organizational needs are incorporated into development plans, including considerations for research and development, design engineering, process development, and commercial manufacturing. Support and promote adherence to applicable medical device regulations and standards throughout the product development life cycle. Contribute to continuous improvement of project management and product development processes by sharing lessons learned and best practices. Essential Skills Proven ability to lead medical device product development as a technical lead or principal engineer. Demonstrated experience managing cross‑functional teams through the full product development life cycle in a regulated medical device environment. Minimum of ten years of previous engineering experience, preferably in medical device product development. Minimum of seven years of project management experience in a regulated medical device environment. Strong project management skills, including planning, scheduling, cost control, risk management, and project coordination. Hands‑on technical expertise in research and development, design engineering, or process development. Experience with product development life‑cycle management and program management for complex technical products. Ability to serve as the primary liaison to stakeholders, delivering clear, timely updates on risks, milestones, and progress. Knowledge of Quality System Regulation (QSR) CFR 820 and applicable ISO standards relevant to medical devices. Experience working in CMO/CDMO medical device environments or similar contract development and manufacturing settings. Strong skills in customer and vendor management, including communication, negotiation, and relationship building. Ability to evaluate and resolve issues impacting manufacturability and reliability of medical devices. Proficiency in applying engineering principles to support investigational and early verification testing. Bachelor of Science degree in Engineering or a closely related technical discipline. Additional Skills & Qualifications Experience with estimation and cost control for engineering and product development projects. Background in scheduling and resource planning for multi‑project portfolios. Exposure to machine shop tools, rapid prototyping, and molding and extrusion methods used in product development. Experience supporting or working within test labs and commercial manufacturing environments. Education or experience specifically focused on research and development, design engineering, or process development. Strong analytical, problem‑solving, and decision‑making skills in a complex, regulated environment. Excellent written and verbal communication skills, with the ability to present technical and program information to diverse audiences. Demonstrated ability to work collaboratively in cross‑functional teams and build cohesive working relationships. Comfort working in a transparent, customer‑facing environment where collaboration with clients is encouraged onsite. Work Environment The role is based in a modern, approximately 120,000 sq. ft. facility that houses a full suite of capabilities to support end‑to‑end medical device product development, including a machine shop, 3D printing resources, a test laboratory, and commercial manufacturing operations. The environment encourages close collaboration with customers, who are regularly invited onsite to work directly with the team, fostering a cohesive and transparent partnership. The culture promotes a friendly, team‑oriented atmosphere with a strong "work hard, party hard" mindset, where colleagues support one another and enjoy a positive, energetic workplace. The facility is designed to support hands‑on engineering work, rapid prototyping, and testing, providing direct access to the tools and equipment needed to move products efficiently from concept to production. Job Type & Location This is a Permanent position based out of Minneapolis, MN. Pay and Benefits The pay range for this position is $125000.00 - $150000.00/yr. 401K Health, dental, vision In house gym HSA options Workplace Type This is a fully onsite position in Minneapolis, MN. Application Deadline This position is anticipated to close on May 22, 2026. Equal Opportunity Statement The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr Actalent